[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Proposed Rules]
[Pages 75082-75085]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30450]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0001; FRL-9372-6]
Notice of Receipt of Several Pesticide Petitions Filed for
Residues of Pesticide Chemicals in or on Various Commodities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of filing of petitions and request for comment.
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SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.
DATES: Comments must be received on or before January 18, 2013.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and email address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
[emsp14]Crop production (NAICS code 111).
[emsp14]Animal production (NAICS code 112).
[emsp14]Food manufacturing (NAICS code 311).
[emsp14]Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed at the end of
the pesticide petition summary of interest.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
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vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.
II. What action is the agency taking?
EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
(21 U.S.C. 346a), requesting the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. The Agency is taking public comment on
the requests before responding to the petitioners. EPA is not proposing
any particular action at this time. EPA has determined that the
pesticide petitions described in this document contain the data or
information prescribed in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the pesticide petitions. After
considering the public comments, EPA intends to evaluate whether and
what action may be warranted. Additional data may be needed before EPA
can make a final determination on these pesticide petitions.
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available online at http://www.regulations.gov.
As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.
New Tolerances
1. PP 2E7980. (EPA-HQ-OPP-2012-0454). Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish
tolerances in 40 CFR part 180 for residues of the fungicide
fenpropidin, 1-[3-[4-(1,1-dimethylethyl) phenyl]-2-methyl-propyl]
piperidine in or on banana, unbagged fruit at 9 parts per million (ppm)
and banana, pulp from unbagged fruit at 0.4 ppm using the Organization
for Economic Cooperation and Development/Maximum residue level (OECD/
MRL) calculator. An adequate, validated method is available for
enforcement purposes (method REM 164.09). Final determination is
carried out with triple quadrupole mass spectrometric detection liquid
chromatography-mass spectrometry ((LC-MS/MS), Applied Biosystems API
3,000 detector). Contact: Tamue L. Gibson, (703) 305-9096, email
address: gibson.tamue@epa.gov.
2. PP 2E8011. (EPA-HQ-OPP-2012-0858). Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC, 27419, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide
thiamethoxam (3-[(2-chloro-5-thiazolyl)methyl] tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) (CAS Reg. No. 153719-23-4) and its
metabolite [N-(2-chloro-thiazol-5-yl)methyl]-N'-methyl-N'-nitro-
guanidine, in or on tea at 20 ppm. Syngenta Crop Protection, LLC, has
submitted practical analytical methodology for detecting and measuring
levels of thiamethoxam in or on raw agricultural commodities. This
method is based on crop specific cleanup procedures and determination
by LC with either ultraviolet (UV) or mass spectrometry (MS)
detections. Contact: Jennifer Urbanski, (703) 347-0156, email address:
urbanski.jennifer@epa.gov.
3. PP 1F7826. (EPA-HQ-OPP-2012-0815). State of Florida, Department
of Citrus, 605 East Main Street, P.O. Box 9010, Bartow, FL 33831-9010,
requests to establish tolerances in 40 CFR part 180 for residues of the
fungicide 5-chloro-3-methyl-4-nitro-1H-pyrazole (CMNP) and its
metabolite (5-chloro-4-nitro-1H-pyrazol-3-yl)-methanol (CHNP), in or on
oranges at 0.80 ppm and its processed commodities: Orange, juice at
0.025 ppm; orange, oil at 0.070 ppm; and orange, dried pulp (also
referred to as dried pomace) at 1.80 ppm. In all plant matrices, the
residue of concern, parent CMNP and CHNP/CHNP glucoside, can be
determined using high performance liquid chromatography/tandem mass
spectrometry (HPLC/MS-MS) following sample extraction, hydrolysis (to
convert CHNP-glucoside to its aglycone, CHNP) and solid-phase clean up.
Contact: Tony Kish, (703) 308-9443, email address: kish.tony@epa.gov.
4. PP 2F8044. (EPA-HQ-OPP-2012-0876). Bayer CropScience, 2 T.W.
Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709,
requests to establish tolerances in 40 CFR part 180 for residues of the
fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-
chlorophenyl-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione
and its desthio metabolite, in or on bushberry crop subgroup 13-07B at
2.0 ppm; low growing berry crop subgroup 13-07H (except strawberry) at
0.15 ppm; and cucurbit vegetables crop group 9 at 0.3 ppm. The
analytical method for determining residues of concern in plants
extracts residues of prothioconazole and JAU6476-desthio and converts
the prothioconazole to JAU6476-desthio and JAU6476-sulfonic acid.
Following the addition of internal standards, the sample extracts are
analyzed by LC/MS/MS. The analytical method for analysis of large
animal tissues includes extraction of the residues of concern, followed
by addition of an internal standard to the extract. The extract is then
hydrolyzed to release conjugates, partitioned and analyzed by LC/MS/MS
as prothioconazole, JAU6476-desthio and JAU6476-4-hydroxy. The method
for analysis of milk eliminated the initial extraction step in the
tissue method. Contact: Rosemary Kearns, (703) 305-5611, email address:
kearns.rosemary@epa.gov.
5. PP 2F8053. (EPA-HQ-OPP-2012-0638). BASF Corporation, 26 Davis
Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, requests
to establish tolerances in 40 CFR part 180 for residues of the
fungicide fluxapyroxad, (BAS 700 F); 1H-Pyrazole-4-carboxamide,3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-,
its metabolites, and degradates, in or on almond at 0.05 ppm; almond,
hulls at 4.0 ppm; berry, low growing, subgroup 13-07G at 4.0 ppm;
bushberry, subgroup 13-07B at 6.0 ppm; caneberry, subgroup 13-07A at
6.0 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 2.0 ppm; grapes at 2.0 ppm; grapes, raisin at 5.7 ppm; pecans
at 0.05 ppm; rice, bran at 8.5 ppm; rice, grain at 5.0 ppm; rice, hulls
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at 15.0 ppm; rice, straw at 20.0 ppm; strawberry at 4.0 ppm; sugarcane,
cane at 3.0 ppm; vegetable, Brassica leafy, group 5 at 3.0 ppm;
vegetable, bulb, group 3-07 at 0.8 ppm; vegetable, cucurbit, group 9 at
0.4 ppm; vegetable, leafy, except Brassica, group 4 at 15.0 ppm;
vegetable, root, except sugar beet, subgroup 1B at 0.7 ppm.
Independently validated analytical methods have been submitted for
analyzing residues of parent BAS 700 F (fluxapyroxad) plus metabolites
M700F008, M700F048 and M700F002 with appropriate sensitivity in all the
crop and processed commodities for root and tuber vegetables, subgroups
1A,1C, D, sugar beet tops, legume vegetables including soybean, group
6, foliage of legume vegetables, group 7, fruiting vegetables, group 8,
pome fruits, group 11, stone fruits, group 12, cereal grains, group 15,
forage, fodder and straw of cereal grains, group 16, cotton, canola,
rapeseed, sunflower, and peanut, and in animal meat, fat, liver and
kidney matrices, poultry meat, fat, liver and skin, milk, cream and
eggs for which tolerances have been established. Contact: Olga Odiott,
(703) 308-9369, email address: odiott.olga@epa.gov.
6. PP 2F8067. (EPA-HQ-OPP-2012-0841). Monsanto Company, 1300 I St.,
NW., Suite 450 East, Washington, DC 20052, requests to establish
tolerances in 40 CFR part 180 for residues of the herbicide dicamba,
(3,6-dichloro-o-anisic and its metabolites 3,6-dichloro-5-hydroxy-o-
anisic acid (5-OH dicamba) and 3,6-dichloro-2-hydroxybenzoic acid
(DCSA), in or on cotton, undelinted seed at 3 ppm and cotton, gin
byproducts at 70 ppm. Adequate enforcement methods are available for
the analysis of residues of dicamba and its relevant metabolites in or
on plant and livestock commodities. Pesticide Analytical Manual (PAM)
Vol. II, lists appropriate analytical methods, based on GC with
electron capture detection (GC/ECD), that are sufficient to provide for
the enforcement of proposed dicamba tolerances in cottonseed and cotton
gin by-products. Contact: Michael Walsh, (703) 308-2972, email address:
walsh.michael@epa.gov.
7. PP 2F8076. (EPA-HQ-OPP-2012-0796). Chemtura Corporation, 199
Benson Rd, Middlebury, CT 06749, requests to establish a tolerance in
40 CFR part 180 for residues of the fungicide ipconazole (2-[(4-
chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-
ylmethyl)cyclopentanol) from the treatment of seed prior to planting in
or on legume vegetables, succulent or dried, crop group 6 at 0.01 ppm.
Analytical methods have been developed, validated (including
radiovalidation), and independently validated for the determination of
ipconazole, triazolylalanine, triazolylacetic acid and
triazolylpyruvate in wheat forage, hay, straw, and grain and in corn
forage, cobs and straw using LC-MS/MS. Contact: Dominic Schuler, (703)
347-0260, email address: schuler.dominic@epa.gov.
8. PP 2F8113. (EPA-HQ-OPP-2012-0885). Syngenta Crop Protection,
LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419-8300,
requests to establish tolerances in 40 CFR part 180 for residues of the
fungicide sedaxane, N -[2-[1,1'-bicyclopropyl]-2-ylphenyl]-3-
(difluoromethyl)-1-methyl-1 H -pyrazole-4-carboxamide, as the sum of
its cis- and trans- isomers, as a seed treatment in or on potato at
0.02 ppm and potato, wet peel at 0.06 ppm. Various crops were analyzed
for sedaxane (parent only) using a procedure for analysis of sedaxane
(SYN524464) that can distinguish between its trans- and cis- isomers
(SYN508210 and SYN508211). Plant matrices using method GRM023.01A, or
modified method GRM023.01B are taken through an extraction procedure
with final determination by high performance liquid chromatography
(HPLC) with triple quadrupole MS detection (LC-MS/MS). Contact: Heather
Garvie, (703) 308-0034, email address: garvie.heather@epa.gov.
Amended Tolerances
1. PP 2F7992. (EPA-HQ-OPP-2012-0575). Syngenta Crop Protection,
LLC, Regulatory Affairs, P.O. Box 18300, Greensboro, NC 27419-8300,
requests to amend the tolerances in Sec. 180.475 for residues of the
fungicide difenoconazole, 1 [2-[2-chloro-4-(4-chlorophenoxy)]phenyl-4-
methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4,-triazole), in or on
vegetables, tuberous and corm, subgroup 1C from 0.01 ppm to 4.0 ppm;
and by removing the established tolerance in or on the raw agricultural
commodity potatoes, processed waste at 0.04 ppm. Syngenta Crop
Protection, Inc., has submitted a practical analytical method (AG-575B)
for detecting and measuring levels of difenoconazole in or on food with
a limit of quantitation (LOQ) that allows monitoring of food with
residues at or above the levels set in the proposed tolerances.
Residues are qualified by LC/MS/MS; and has submitted a practical
analytical method (AG-544A) for detecting and measuring levels of
difenoconazole in or on cattle tissues and milk and poultry tissues and
eggs, with a LOQ that allows monitoring of food with residues at or
above the levels set in the proposed tolerances. Contact: Rosemary
Kearns, (703) 305-5611, email address: kearns.rosemary@epa.gov.
2. PP 2F8076. (EPA-HQ-OPP-2012-0796). Chemtura Corporation, 199
Benson Rd, Middlebury, CT 06749, requests to amend the tolerance in
Sec. 180.646 for residues of the fungicide ipconazole, (2-[(4-
chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-
ylmethyl)cyclopentanol) by deleting the tolerance for pea and bean,
dried shelled, except soybean, subgroup 6C at 0.01 ppm, upon approval
of legume vegetables (succulent or dried), crop group 6 at 0.01 ppm
under ``New Tolerance'' for PP 2F8076. Contact: Dominic Schuler, (703)
347-0260, email address: schuler.dominic@epa.gov.
3. PP 2F8085. (EPA-HQ-OPP-2012-0843). Dow AgroSciences, LLC, 9330
Zionsville Road, Indianapolis, IN 46268, requests to amend the
tolerances in Sec. 180.560 for the combined residues of cloquintocet-
mexyl (acetic acid, [(5-chloro-8-quniolinyl)oxy]-, 1-methylhexyl ester)
(CAS No. 99607-70-2) and its acid metabolite (5-chloro-8-
quinlinoxyacetic acid), when used as an inert ingredient (safener) in
pesticide formulations containing the new active ingredient halauxifen-
methyl (XDE-729 methyl), in or on barley, grain at 0.1 ppm; barley, hay
at 0.1 ppm; barley, straw at 0.1 ppm; wheat, forage at 0.2 ppm; wheat,
grain at 0.1ppm; wheat, hay at 0.5 ppm; and wheat, straw at 0.1 ppm.
Specifically, this pesticide petition proposes to amend the tolerance
expression by adding a reference to the new herbicide active ingredient
halauxifen-methyl (XDE-729 methyl). Tolerances are already established
for use of cloquintocet-mexyl in conjunction with other herbicides.
This petition will not change the established tolerance levels.
Adequate enforcement methodology is available to enforce the tolerance
expression in the Federal Register of June 29, 2011 (76 FR 38035) (FRL-
8877-2). There are two enforcement methods available. The HPLC with
Ultraviolet Detection (HPLC/UV) method REM 138.01 is for the
determination of cloquintocet-mexyl (parent) and the HPLC/UV Method REM
138.10 allows determination of its acid metabolite (also known as CGA-
153433). Contact: Mindy Ondish, (703) 605-0723, email address:
ondish.mindy@epa.gov.
New Tolerance Exemptions
1. PP 2E8027. (EPA-HQ-OPP-2012-0777). Honeywell International,
Inc., 101 Columbia Road, Morristown, NJ 07962-1053, requests to
establish an
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exemption from the requirement of a tolerance for residues of trans-1-
chloro-3,3,3-trifluoropropene (CAS No. 102687-65-0) under Sec. Sec.
180.910, 180.930, and 180.940 when used as a pesticide inert ingredient
(propellant) in pesticide formulations. No analytical method is
included as this is a petition for exemption from the requirements of a
tolerance. Contact: Lisa Austin, (703) 305-7894, email address:
austin.lisa@epa.gov.
2. PP 2E8082. (EPA-HQ-OPP-2012-0789). Sekisui Specialty Chemicals,
1501 West, LBJ Freeway, Dallas, TX 75234, requests to establish an
exemption from the requirement of a tolerance for residues of 2-
pyrrolidone, 1-ethenyl-, polymer with ethenol (CAS No. 26008-54-8)
under Sec. 180.960 when used as a pesticide inert ingredient in
pesticide formulations for a packaging film for unit dose packaging of
pesticides and pool sanitizers. The petitioner believes no analytical
method is needed because it is not required for the establishment of a
tolerance exemption for inert ingredients. Contact: David Lieu, (703)
305-0079, email address: lieu.david@epa.gov.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: December 11, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-30450 Filed 12-18-12; 8:45 am]
BILLING CODE 6560-50-P